A cross-sectional study of support services influencing patient enrollment decisions in clinical trials.
137 Background: Though clinical trial (CT) participation barriers are well-characterized, there’s limited evidence on strategies to overcome them. We conducted a cross-sectional study to assess the relative impact of specific support services on patients’ (pts) decision to enroll if offered a CT. Methods: We thematically categorized known CT participation barriers and mapped their corresponding pt support resources, reported publicly from sponsors, pt groups, and health systems to develop 4 survey items on pt’s perceived helpfulness of each resource on their trial participation decision (5-point Likert scale). After IRB approval, pts with current or prior lung cancer were recruited (12/30/24–1/10/25) via Lung Cancer Research Foundation & social media. Analysis included descriptive statistics, response grouping, and coding of free-text responses. Results: Overall, 314 pts with lung cancer completed the survey, 58% aged 40-64y, 37% 65y+, 6% AYA 18-39y; 78% were female, 62% had metastatic disease, 78% never participated in a CT. Four key thematic solutions with respective support services targeting CT access barriers were identified: Enhanced Expert Support: Over 90% of pts report having increased support from professionals—inc. access to CT team, frequent check-ins about symptoms, and personalized guidance from a trained trial navigator—would make them more likely to enroll. Pts 65y+ were more likely to enroll if given more opportunities to report symptoms (93% vs 82%, p 0.008). Cost-Informed Pt Engagement: Over 80% were more likely to consent if (1) told their expected out-of-pocket costs during CT participation for services not covered, (2) provided financial resources, inc. full medication coverage for side effects, travel for CT activities; 62% were more likely to consent if housing, gas, and meal costs were covered. Multi-Modal On-Demand Education: Over 80% were more likely to consent if provided on-demand education, inc. (1) video from the PI on side effects & management, esp. pts aged 65+ (87% vs 77% of pts < 65y, p 0.038); (2) one-pager on key CT aspects ( process, time commitment), esp. non-partnered pts (92% vs 79% for partnered pts, p 0.021). Over 70% also wanted a list of questions to ask their medical team, diagnosis info, and a video from the PI on CT design and consent process. Time-Conscious Pt Experience: Over 90% were more likely to consent if offered coordination of appointments/scans & increased flexibility with scheduling. Over 80% also ranked having video/ phone visits and optional blood draws at home/location of choice to be influential in consenting. Conclusions: Our findings highlight four key solutions that influence CT participation and offer actionable recommendations—such as expert support, clear education, and time/cost transparency—for sponsors, regulators, and others to proactively make CTs more accessible.
Authors
- Cardinale B. Smith (ORCID: https://orcid.org/0000-0003-3635-8701)
- Eric Kumar Singhi (ORCID: https://orcid.org/0000-0001-5918-9168)
- Robert Michael Daly (ORCID: https://orcid.org/0000-0001-7360-0558)
- Ishwaria M. Subbiah (ORCID: https://orcid.org/0000-0002-0758-7911)
- Andrea Arfè (ORCID: https://orcid.org/0000-0003-1534-0609)
- Terri Conneran
- Isabel R. Preeshagul (ORCID: https://orcid.org/0000-0002-4504-4520)
- Jonathan M. Feldman (ORCID: https://orcid.org/0000-0002-7326-3026)
- Marcia K. Horn (ORCID: https://orcid.org/0000-0001-6505-3355)
- Devika Das (ORCID: https://orcid.org/0009-0002-1821-5985)
- Mark M. Awad (ORCID: https://orcid.org/0000-0003-0928-5244)
- Antoinette J. Wozniak
Institutions
- Memorial Sloan Kettering Cancer Center (US)
- The University of Texas MD Anderson Cancer Center (US)
- University of Florida (US)
- Lung Cancer Research Foundation (US)
Publication Details
- Journal
- JCO Oncology Practice
- Published
- 2025-10-01
- DOI
- https://doi.org/10.1200/op.2025.21.10_suppl.137
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 0.00